Left atrial appendage closure device with catheter-based delivery

Abstract

Instruments and methods are disclosed for left atrial appendage (LAA) closure. An exemplary occluder comprises a lattice framework and an anchor. An exemplary delivery tool provides a catheter-based means of delivery of the occluder to the left atrium and LAA of a heart, such as a human heart, and deployment of the occluder by minimally invasive surgery.

1 - 61 . (canceled) 
     
     
         62 . An occluder for a left atrial appendage (LAA) of a heart, comprising:
 a collapsible stent umbrella at a first end;   an anchor at second end;   and at least one of
 a pair of moveable jaws on opposite sides of the anchor, sized to capture tissue of a wall of the LAA and permit the anchor to be secured to the captured tissue, and 
 a longitudinal opening at a center of the stent umbrella and one or more notches which open in a direction of the first end. 
   
     
     
         63 . The occluder of  claim 62 , wherein the one or more notches includes at least two notches positioned on opposite sides of the longitudinal opening. 
     
     
         64 . The occluder of  claim 62 , wherein the anchor has a diameter of 1-3 mm. 
     
     
         65 . The occluder of  claim 62 , further comprising a longitudinally oriented pass through opening sized to permit guide wire insertion, tracking, and removal. 
     
     
         66 . The occluder of  claim 62 , wherein the anchor is in a form of a helical coil, or in a form of a hook. 
     
     
         67 . The occluder of  claim 62 , wherein the pair of moveable jaws are made from super-elastic or shape memory metal or metal alloy. 
     
     
         68 . The occluder of  claim 62 , further comprising an insert positioned at a center of the stent umbrella, wherein the pair of moveable jaws are secured to the insert. 
     
     
         69 . An occluder as recited in  claim 62  wherein the collapsible stent umbrella comprises
 a lattice framework formed from a super-elastic or shape memory metal or metal alloy which is annealed and quenched so as to set the lattice framework in a heat set deployed shape, wherein the lattice framework is deformable and returnable to the deployed shape via material super-elasticity, or wherein at body temperature the lattice framework assumes the heat set deployed shape in an absence of restricting external forces via material shape memory, wherein at freezing or near freezing temperatures the lattice framework is collapsible to a tubular shape, and wherein the lattice framework is sized to extend over an LAA ostium of a heart; and 
 a fabric covering affixed to the lattice framework; and wherein the anchor is 
 a coil anchor secured to or integrally formed with the lattice framework, wherein the coil anchor is a helical coil with a sharpened end opposite the lattice framework. 
 
     
     
         70 . The collapsible occluder of  claim 69 , wherein the fabric covering is or has at least one of:
 is a woven polyethylene terephthalate which is structured to facilitate tissue in-growth and encapsulation;   has attachment holes on lattice members at a circumferential periphery of the stent umbrella, and wherein the fabric covering is secured to the attachment holes;   is an expanded polytetrafluoroethylene (ePTFE) or other medical fabric material which is structured to facilitate tissue in-growth and encapsulation;   
       has attachment holes on lattice members at a circumferential periphery of the lattice framework, and wherein the fabric covering is secured to the attachment holes;
 has rounded stent tips on lattice members at a circumferential periphery of the lattice framework; and 
 is attached directly to struts of the lattice framework. 
 
     
     
         71 . The occluder of  claim 69 , wherein the coil anchor and the lattice framework are
 integrally formed from a single piece of super-elastic or shape memory material, or   integrally formed from multiple pieces of super-elastic or shape memory material.   
     
     
         72 . A method for occluding a left atrial appendage (LAA) of a heart, comprising:
 positioning in the LAA an implant including an occluding portion and an anchoring portion, wherein the occluding portion has a collapsible lattice framework which is in a collapsed tubular shape during the positioning step;   grasping together a portion of an inside wall of LAA to produce a thickened tissue section;   anchoring the anchor portion to the thickened tissue section of the LAA; and   
       deploying the occluding portion in the left atrium so as to provide a seal between the left atrium and the LAA. 
     
     
         73 . The method of  claim 72  wherein the steps include
 steering a catheter which delivers the occluder in a collapsed state to the LAA; 
 anchoring an anchor of the occluder to the inner wall of the LAA via a transfer of torque from a delivery tool to the anchor of the occluder; 
 deploying a lattice framework of the occluder to a deployed position in a left atrium of the heart and covering an opening to the LAA; and 
 releasing the delivery tool from the occluder. 
 
     
     
         74 . A method for occluding a left atrial appendage (LAA) of a heart, comprising:
 positioning a sheath with an occluder therein at the LAA, wherein the occluder comprises
 a collapsible stent umbrella at a first end, 
 an anchor at a second end, 
 a threaded longitudinal opening at a center of the collapsible stent umbrella, and 
 one or more notches which open in a direction of the first end; 
   securing the anchor of the occluder to an inside wall of the LAA;   while holding the occluder stationary using a holding rod that interfaces with the one or more notches on the occluder, retracting the sheath from the occluder to deploy the collapsible stent umbrella to a deployed position in a left atrium of the heart and covering an opening to the LAA; and   unscrewing a threaded rod from the threaded longitudinal opening to leave the occluder in the LAA.   
     
     
         75 . A control handle for a catheter delivery tool for installing an occluder in a left atrial appendage (LAA) of a heart, wherein the occluder comprises a collapsible stent umbrella at a first end, an anchor at a second end, a threaded longitudinal opening at a center of the stent umbrella, and one or more notches which open in a direction of the first end; the control handle comprising:
 a primary handle;   a steerable catheter handle connected to the primary handle; and   one or more actuators for
 steering a catheter which delivers the occluder to the LAA, 
 anchoring the anchor to an inner wall of the LAA, 
 deploying the collapsible stent umbrella to a deployed position in a left atrium of the heart and covering an opening to the LAA, and 
 releasing the catheter delivery tool from the occluder once the occluder is installed at the LAA. 
   
     
     
         76 . A surgical system for occluding a left atrial appendage (LAA) of a heart, comprising:
 an implant comprising
 a collapsible lattice framework, 
 an anchor, and 
 a first interface; and 
   a delivery tool for implanting the implant in the heart, the delivery tool comprising
 a second interface configured for holding the implant such that the implant is pushable and pullable and for transferring torque to the first interface to secure the anchor in tissue of the LAA, and 
 a sheath in which the implant is positionable in a collapsed state, and 
 one or more actuators for deploying the implant from a distal end of the sheath. 
   
     
     
         77 . A delivery tool for surgical implantation of an implant, comprising:
 an interface configured for holding the implant such that the implant is pushable and pullable and for transferring torque to the implant;   a sheath in which the implant is positionable in a collapsed state; and   one or more actuators for deploying the implant from a distal end of the sheath,   wherein the sheath and the interface are moveable relative to one another such that the interface is moveable between a first position inside the sheath to a second position outside the sheath.